check_circleStudy Completed

Diabetes Mellitus

Bayer Identifier:

13066

ClinicalTrials.gov Identifier:

NCT01167231

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease

Trial purpose

The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Diabetes Mellitus
    - Age >/= 18 years
    - Naive to acarbose (minimum 3 months before inclusion)
  • - Hypersensitivity to acarbose or any of the excipients
    - Age <18 years
    - Pregnancy and in nursing
    - Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
    - Chronic intestinal diseases associated with marked disorders of digestion or absorption
    - States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld’s syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach] and larger hernias)
    - Hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)

Trial summary

Enrollment Goal
3310
Trial Dates
May 2007 - June 2008
Phase
N/A
Could I Receive a placebo
No
Products
Acarbose (Precose/Glucobay, BAYG5421)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure
    date_rangeTime Frame:
    approximately 6 months after acarbose treatment initiation
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    Safety Issue:
    No

Secondary Outcome

  • Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile
    date_rangeTime Frame:
    approximately 6 months after acarbose treatment initiation
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    Safety Issue:
    Yes

Trial design

Acarbose in cardiovascular risk management. Assessment of clinical efficacy and safety of acarbose and its effect on selected cardiovascular risk factors in type 2 diabetes patients.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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